Vaccine Therapy in Treating Patients With Metastatic Melanoma
Mature Dendritic Cell Immunotherapy Of Metastatic Melanoma- A Phase I Trial
RATIONALE: Vaccines made from a patient's white blood cells mixed with tumor antigens may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma.
연구 개요
상세 설명
OBJECTIVES:
- Determine the safety and tolerability of antigen-pulsed dendritic cell vaccine in patients with metastatic melanoma.
- Determine the longevity of melanoma-specific immunity in patients treated with this regimen.
- Perform serial analysis of T-cell and B-cell function in patients treated with this regimen.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 1-6 or 1-7. Patients undergo apheresis on days 6 and 7 or 6-8 to obtain peripheral blood mononuclear cells (PBMC). PBMC are processed for CD34+ cell isolation. These autologous CD34+ hematopoietic progenitor cells are cultured to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin and HLA-A2-01 restricted flu-matrix peptides derived from melanoma-associated tumor antigens (MART-1:27-35, gp100:209-217, and MAGE-3). Antigen-pulsed DC are incubated with interferon alfa to induce DC maturation.
Patients receive priming injections of antigen-pulsed DC vaccine SC once every 2 weeks for 8 weeks. Treatment repeats at 2, 3, 4, and 5 months after the last priming injection in the absence of unacceptable toxicity or disease progression.
Patients are followed at 2 and 4 weeks and then every 3 months for 1.5 years.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.
연구 유형
단계
- 1단계
연락처 및 위치
연구 장소
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Texas
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Dallas, Texas, 미국, 75246
- Baylor University Medical Center
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참여기준
자격 기준
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연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic melanoma
- HLA-A2-01 phenotype
- Measurable disease
- No active CNS or hepatic metastases
PATIENT CHARACTERISTICS:
Age:
- 21 and over
Performance status:
- Karnofsky 80-100%
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- See Disease Characteristics
- No viral hepatitis
Renal:
- Not specified
Cardiovascular:
- No prior venous thrombosis, angina pectoris, or congestive heart failure
- Lactate dehydrogenase less than 2 times normal
Pulmonary:
- No prior asthma
Immunologic:
- Intradermal skin test positivity to mumps, Candida, or streptokinase antigen
- No known sensitivity to E. coli drug preparations
- No prior allergy to influenza vaccine
- No active infection
- No prior autoimmune disease (e.g., lupus erythematosus, rheumatoid arthritis, or thyroiditis)
Other:
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 8 weeks since prior interleukin-2
- At least 4 weeks since prior interferon alfa
Chemotherapy:
- At least 8 weeks since prior chemotherapy
Endocrine therapy:
- At least 2 weeks since prior corticosteroids
- No concurrent corticosteroids
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
- No concurrent immunosuppressive agents
- At least 2 weeks since prior immunosuppressive agents
공부 계획
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디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 등록 날짜
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처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000068680
- BAYUMC-000048
- NCI-4170
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